ClinicalTrials.gg
CompletedNCT03368950Updated Dec 22, 2023

Online Mindfulness for Stroke Sufferers

An interventional study of Online Mindfulness Course in Stroke, sponsored by University of Surrey. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-22.

Sponsored by University of Surrey · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jun 2017, registered Oct 2017).

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 371 studies in Stroke with a site in United Kingdom — 59 open to participants now, 79 under way, 8 of them phase 3. Stroke · United Kingdom.

Enrollment
174th of 256
30 · median 62
Started
2017
with 25 others
No phase
148 of 371
22 open now
Registered
186th of 371
by date

Among the 371 studies in Stroke with a site in United Kingdom, this one is the 174th largest by enrollment of the 256 interventional ones that give a count, is one of 26 that started in 2017, is one of 148 with no phase, and was the 186th registered.

Stroke

8,258 studies on the registry are indexed under Stroke; 2,055 are open to participants now.

Browse Stroke studies →

Open to participants now

59 of the 371 studies in Stroke with a site in United Kingdom are open now. Recruiting first, the newest first:

54 more — sign in →

All 59 open studies →

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 1,415 Stroke studies recruiting now, 695 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 195 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 371 studies in Stroke with a site in United Kingdom, or all of them as a file.
02

Study summary

A feasibility study to investigate the effect of an online mindfulness programme (www.bemindfulonline.com) on stroke survivors' mental and physical wellbeing.

Read the detailed description

Anxiety and depression is common to those post-stroke with about a third of stroke sufferers experiencing one or both. It is felt these are currently underdiagnosed and undertreated. There is a call for more accessible interventions. Mindfulness based interventions have shown considerable efficacy in treating anxiety and depression and there is growing body of evidence of the benefits of mindfulness for those post-stroke. This study will be the first to look at an instructor-led online mindfulness intervention for stroke sufferers. As a feasibility study it aims to investigate whether such an intervention is acceptable to patients and if so, can a larger scale study be done. The larger scale study will investigate whether the intervention is beneficial in reducing anxiety and depression. This study will assess the design and intervention format required to test this. Those who have had a stroke and are eligible to participate in the online mindfulness course will be invited to take part by their stroke specialist nurse. The 10 session course teaches participants mindfulness skills through audio and visual clips. Each week participants will be asked to complete one of each as well as do an informal exercise in their own time. It will take approximately 6-8 weeks to complete the course. The study will collect information from participants via online questionnaires before starting, during and at the end of the course. The questionnaires will ask about anxiety, depression, thinking style, health, quality of life and perceived stress levels. The investigators will not evaluate the outcomes but instead look at response rates and calculate standard deviations of the measures used to help us calculate the sample size needed for the larger study. The investigators will also look at the willingness of clinicians to recruit participants. Additionally, the study will involve interviews with a subset of participants to assess their experience of the study design and to explore the acceptability of the online mindfulness intervention in this population.

03

Conditions studied

  • Stroke

Keywords

  • Anxiety
  • Depression
  • Stress
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • More than 4 months post-stroke, when physical and social recovery will have stabilised and likely longer term problems can be assessed
  • Those who express an interest in being involved in a study for those with emotional changes following stroke
  • Have internet access at home or on tablet or smartphone, with access to speakers or headphones
  • Are able to commit to two hours (minimum) per week for the duration of the course (6-8 weeks)
  • Are able to understand the research materials.

Exclusion criteria

Exclusion Criteria:

  • Under 18 years old, to exclude childhood stroke (predominantly caused by congenital heart disease or sickle cell disease, whereas adult stroke is predominantly caused by atherosclerosis).
  • Receiving another psychological intervention or mindfulness training at the time of study
  • Actively psychotic, having received a diagnosis of dementia or a learning disability
  • Severe mental health difficulties based on judgement of referring clinician
  • Significant cognitive difficulties which would impact ability to access intervention despite prompting and support.
  • Unable to read or understand English
  • Without an email address or access to trusted family members email address
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Intervention

    Participants in this arm are invited to undertake an 8-week online mindfulness course

    Other: Online Mindfulness Course

  • Active comparator
    Wait list

    Participants in this arm are informed they are on a wait list and are required to wait 8 weeks, before being invited to take part in the intervention itself (an 8-week online mindfulness course).

    Other: Online Mindfulness Course

Interventions

  • OtherOnline Mindfulness Course

    An online mindfulness course guiding participants through all elements of Mindfulness-Based Cognitive Therapy (MBCT) and Mindfulness-Based Stress Reduction (MBSR). Ten easy-to-follow sessions with videos and interactive exercises led by leading mindfulness trainers.

06

What researchers measure

Primary outcomes

  1. Change to Stress Scale Score

    Perceived Stress Scale (PSS) Questionnaire (scores range from 0-40 with a higher score indicating higher and therefore worsened stress levels)

    Time frame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.

Secondary outcomes

  1. Change to Anxiety Measure Score

    Generalised Anxiety Disorder (GAD7) Questionnaire consisting of 7 items (scores range from 0-21 with a higher score indicating higher and therefore worsened anxiety levels)

    Time frame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.

  2. Change to Depression Measure Score

    Patient Health Questionnaire (PHQ9) Questionnaire consisting of 9 items (scores range from 0-27 with a higher score indicating worsened depression symptomatology)

    Time frame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.

  3. Change to Mindfulness Measure Score

    Five Facet Mindfulness Questionnaire - Short form - Questionnaire produces a total score and 5 subtest scores for different facets of mindfulness: Observing, Describing, Acting with Awareness, Non-Judging of inner experience, and Non-Reactivity to inner experience from 15 items. A higher score indicates greater (and therefore better) self-reported level of mindfulness skills.

    Time frame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.

  4. Change to Worry and Rumination Measure Score

    Perseverative Thinking Questionnaire (PTQ) consisting of 15 items (scores range from 0-60 with a higher score indicating a higher level of, and therefore worsened perseverative and ruminative thinking.

    Time frame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.

  5. Change to Health Status Measure

    EQ5DL Questionnaire consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. A chosen health state is indicated by ticking the box next to the most appropriate statement resulting in a 1-digit number. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state (with a lower score indicating no health issues i.e. better health). The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. Scores range from 0-100 with a higher score indicating better health.

    Time frame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.

  6. Change to Stroke Specific Quality of Life Measure

    Stroke Specific Quality of Life 12-item Scale consists of 12 domains relating to: energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper extremity function, vision and work/productivity. Participants indicate how much their stroke has negatively impacted their functioning in each domain (with answers ranging from 'couldn't do it at all' to 'no trouble at all', strongly agree/disagree, 'total help' to 'no help needed').

    Time frame: Pre and Post Intervention, and at 3 and 6 months post-intervention follow up.

07

Study locations

1 site
  • First Community Health and Care (FCHC)
    Caterham, Surrey, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2017 to primary completion in Jun 2018, 12 months.

Of 3,111 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 12 months is below that.

Counting every sponsor, half of 3,255 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 11, 2017
First posted
Dec 11, 2017
StartActual
Jun 1, 2017
Primary completionActual
Jun 1, 2018
CompletionActual
Sep 1, 2018
Last update
Dec 22, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03368950
Lead sponsor
University of Surrey
Collaborators
First Community Health and Care, Surrey and Borders Partnership NHS Foundation Trust
Responsible party
Sponsor
First posted
Dec 11, 2017
Start date
Jun 1, 2017
Primary completion
Jun 1, 2018
Completion
Sep 1, 2018
Last update
Dec 22, 2023

Study contacts

Chris Fife-Schaw, Professor
study chair · University of Surrey, Project Supervisor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion